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ReNeuron - UK approval for landmark stroke clinical trial
ReNeuron Group plc have announced that the UK Gene Therapy Advisory Committee (GTAC) has given a full and final Favourable Opinion to ReNeuron’s proposed first-in-man clinical trial with its ReN001 stem cell therapy for stroke. GTAC acts as the national research ethics committee for gene therapy and stem cell therapy clinical trials in the UK.
This approval represents the final national regulatory step in taking the ReN001 therapy into patients in the UK, following regulatory approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) last year. The Company is now working with its chosen contract research organisation (CRO) to finalise local arrangements for the clinical trial at the trial site as well as completing various other contractual, registration and documentation requirements, after which patient recruitment and evaluation for the trial will begin, most likely in April of this year. Further information regarding patient recruitment for the clinical trial will be made available by the centre concerned in due course.
